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Lantus Safety Reports

Total Lantus reports: 1128.
Lantus FDA safety alerts: No.
Reported deaths: 91    Reported hospitalizations: 445.
Take Lantus Side Effects Survey or Share Your Lantus Story.
Reported Lantus Side Effects: blood glucose increased, hyperglycaemia, blood glucose decreased, hypoglycaemia unawareness, hypoglycaemia, hypoglycaemia neonatal, blood glucose fluctuation, asthenia, diabetic ketoacidosis, loss of consciousness, malaise.
Lantus Usage.

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Lantus Side Effects Report #5254077-4
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Feb 24, 2007. Female patient, 77 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, blood pressure increased, renal artery occlusion, renal function test abnormal. LANTUS dosage: unknown. During the same period patient was treated with COREG, ASPIRIN, ZETIA, ACCUPRIL, LASIX, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5254078-6
LANTUS problem was reported by a Physician from BRAZIL on Feb 23, 2007. Female patient, 84 years of age, weighting 154.3 lb, was diagnosed with hypertension, blood cholesterol, abdominal pain upper, diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: dizziness, enteritis, hospitalisation, hyperglycaemia, hyperhidrosis, hypoglycaemia. LANTUS dosage: unknown. During the same period patient was treated with OPTIPEN, LOSARTAN POTASSIUM, SINVASCOR, ALCADIL, NOVORAPID. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5254079-8
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Feb 28, 2007. Male patient, 85 years of age, was diagnosed with diabetes mellitus insulin-dependent and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, cardiac failure, myocardial infarction. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, NOVOLOG, PLAVIX, TOPROL. Patient was hospitalized. Patient died on 12/16/2006.

Lantus Side Effects Report #5255243-4
LANTUS problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Feb 21, 2007. Female patient, weighting 242.5 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: tachycardia. LANTUS dosage: unknown. During the same period patient was treated with PREDNISOLONE, GABAPENTIN, RABEPRAZOLE, IRBESARTAN, AMLODIPINE, BUMETANIDE, ALENDRONIC ACID, ASPIRIN. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5255244-6
Consumer or non-health professional from BRAZIL reported LANTUS problem on Feb 26, 2007. Female patient, weighting 125.7 lb, was diagnosed with hypothyroidism, depression, anxiety and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: depression, fatigue, hyperglycaemia, ketoacidosis. LANTUS dosage: unknown. During the same period patient was treated with OPTIPEN, PURAN T, FLUOXETINE, BIOGLIC, RIVOTRIL, METFORMIN. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5255246-X
LANTUS problem was reported by a Physician from ITALY on Feb 28, 2007. Male patient was diagnosed with diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: alcohol use, device failure, diabetic ketoacidosis, feeding disorder. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5255247-1
Physician from BRAZIL reported LANTUS problem on Feb 27, 2007. Female patient, 13 years of age, weighting 103.6 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: hyperglycaemia, polydipsia, vomiting. LANTUS dosage: unknown. During the same period patient was treated with AUTOPEN INSULINECTION PEN. Patient recovered.

Lantus Side Effects Report #5255248-3
LANTUS problem was reported by a Physician from SPAIN on Feb 27, 2007. Male patient, 56 years of age, weighting 231.5 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: leukocytoclastic vasculitis, skin necrosis. LANTUS dosage: unknown. During the same period patient was treated with GLYBURIDE, METFORMIN, ASPIRIN. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5256040-6
Pharmacist from UNITED STATES reported LANTUS problem on Mar 02, 2007. Male patient, 70 years of age, was diagnosed with diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, tremor, unresponsive to stimuli. LANTUS dosage: unknown. During the same period patient was treated with AVAPRO, AMBIEN, ASPIRIN, COREG, COUMADIN, ALDACTONE, CRESTOR, LASIX. Patient recovered.

Lantus Side Effects Report #5256315-0
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 23, 2007. Male patient, 59 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: condition aggravated, muscle disorder, myasthenia gravis. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, PREDNISONE, MESTINON, IMURAN, GLUCOPHAGE. Patient recovered.

Lantus Side Effects Report #5256316-2
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Feb 27, 2007. Female patient, 71 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: cough, enterocolitis infectious, eye disorder, sinusitis, vision blurred. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, AVANDIA, METOPROLOL SUCCINATE, ALTACE, SIMVASTIN, ASPIRIN. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5256317-4
LANTUS problem was reported by a Consumer or non-health professional from on Mar 01, 2007. Female patient, 27 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: meningocele. LANTUS dosage: unknown. During the same period patient was treated with INSULIN ASPART. Patient recovered.

Lantus Side Effects Report #5257249-8
Consumer or non-health professional from UNITED KINGDOM reported LANTUS problem on Feb 27, 2007. Female patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood ketone body increased, dehydration, hyperglycaemia, influenza. LANTUS dosage: unknown. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5258722-9
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 02, 2007. Female patient, 68 years of age, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: cataract, eye irritation. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, GLYBURIDE, METFORMIN, ACETYLSALICYLIC ACID SRT, ZYRTEC, BUSPIRONE. Patient recovered.

Lantus Side Effects Report #5258723-0
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Mar 02, 2007. Female patient, 35 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, vision blurred. LANTUS dosage: unknown. During the same period patient was treated with GLUCOPHAGE, GLUCOTROL. Patient recovered.

Lantus Side Effects Report #5258724-2
LANTUS problem was reported by a Physician from SERBIA AND MONTENEGRO on Mar 02, 2007. Male patient, 53 years of age, weighting 266.8 lb, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: confusional state, encephalitis, melaena. LANTUS dosage: unknown. During the same period patient was treated with OPTIPEN, SIOFOR. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5259866-8
Health Professional from UNITED STATES reported LANTUS problem on Feb 28, 2007. Male patient, weighting 99.65 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, diabetic ketoacidosis, lethargy. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, NOVOLOG, HYDROCORTISONE, PREVACID, RANITIDINE. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5262438-2
LANTUS problem was reported by a Physician from FINLAND on Mar 04, 2007. Female patient, child 2 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: dizziness, off label use, status epilepticus. LANTUS dosage: unknown. During the same period patient was treated with NOVORAPID, DIFLUCAN. Patient recovered.

Lantus Side Effects Report #5262439-4
Physician from KOREA, REPUBLIC OF reported LANTUS problem on Mar 06, 2007. Male patient, 56 years of age, was diagnosed with diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: anorexia, glycosylated haemoglobin increased, weight decreased. LANTUS dosage: unknown. During the same period patient was treated with REPAGLINIDE, GLIMEPIRIDE. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5262440-0
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 06, 2007. Male patient, 70 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: injection site extravasation. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, TORSEMIDE, THEOPHYLLINE, COREG, PREDNISONE, ALTACE, ZOLOFT, VYTORIN. Patient died on 07/28/2006.

Lantus Side Effects Report #5262442-4
Physician from ITALY reported LANTUS problem on Mar 07, 2007. Male patient was diagnosed with diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: alcohol use, device malfunction, diabetic ketoacidosis, feeding disorder, ketosis. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5263710-2
LANTUS problem was reported by a Physician from BRAZIL on Mar 01, 2007. Female patient, 42 years of age, weighting 127.9 lb, was diagnosed with hyperthyroidism and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, hyperglycaemia, ketosis. LANTUS dosage: unknown. During the same period patient was treated with OPTIPEN, EUTHYROX. Patient recovered.

Lantus Side Effects Report #5264715-8
Consumer or non-health professional from JAPAN reported LANTUS problem on Mar 06, 2007. Male patient, weighting 176.4 lb, was diagnosed with diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, depressed level of consciousness, fall, hypoglycaemia. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, HUMALOG. Patient recovered.

Lantus Side Effects Report #5264716-X
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 06, 2007. Female patient, 80 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: aortic stenosis, blood glucose decreased, blood glucose increased, cardiac murmur, dizziness, glycosylated haemoglobin increased, laboratory test abnormal, nervousness. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, AVAPRO, CADUET, ASPIRIN, NOVOLOG, TOPROL. Patient recovered.

Lantus Side Effects Report #5264718-3
Consumer or non-health professional from reported LANTUS problem on Mar 08, 2007. Female patient, 27 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: meningocele. LANTUS dosage: unknown. During the same period patient was treated with INSULIN ASPART. Patient recovered.

Lantus Side Effects Report #5266331-0
LANTUS problem was reported by a Health Professional from GREECE on Mar 12, 2007. Female patient, 38 years of age, weighting 257.9 lb, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: weight increased. LANTUS dosage: unknown. During the same period patient was treated with LISPRO, DIOVANE, CARVEDILOL, GLUCOPHAGE. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5268453-7
Consumer or non-health professional from SPAIN reported LANTUS problem on Mar 07, 2007. Male patient, 69 years of age, weighting 168.7 lb, was diagnosed with hypertension and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: effusion, erythema, formication, hyperglycaemia. LANTUS dosage: unknown. During the same period patient was treated with ARADOIS, AMARYL. Patient recovered.

Lantus Side Effects Report #5268455-0
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 06, 2007. Female patient, 80 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: aortic stenosis, blood glucose decreased, blood glucose increased, cardiac murmur, dizziness, glycosylated haemoglobin increased, laboratory test abnormal, nervousness. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, AVAPRO, CADUET, ASPIRIN, NOVOLOG, TOPROL. Patient recovered.

Lantus Side Effects Report #5269938-X
Health Professional from UNITED STATES reported LANTUS problem on Mar 09, 2007. Female patient, 14 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: dyspnoea, heart rate irregular, malaise. LANTUS dosage: unknown. During the same period patient was treated with ALBUTEROL. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5270508-8
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 05, 2007. Male patient, weighting 295.4 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: weight increased. LANTUS dosage: unknown. During the same period patient was treated with HUMALOG, PROPRANOLOL, ZETIA, ASPIRIN, LEVOCARNITINE, HYDROCHLORTHIAZID, NIACIN. Patient recovered.

Lantus Side Effects Report #5271133-5
Health Professional from GREECE reported LANTUS problem on Mar 14, 2007. Female patient, 38 years of age, weighting 257.9 lb, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: weight increased. LANTUS dosage: unknown. During the same period patient was treated with LISPRO, DIOVAN, CARVEDILOL, GLUCOPHAGE. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5272349-4
LANTUS problem was reported by a Physician from UNITED STATES on Mar 12, 2007. Male patient, 68 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: angle closure glaucoma, retinal haemorrhage. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5272350-0
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Mar 13, 2007. Male patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: eye haemorrhage. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5272921-1
LANTUS problem was reported by a Health Professional from IRELAND on Oct 13, 2006. Male patient, weighting 11.38 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: sepsis, transient tachypnoea of the newborn. LANTUS dosage: unknown. During the same period patient was treated with HUMALOG, NOVORAPID. Patient recovered.

Lantus Side Effects Report #5272924-7
Pharmacist from GERMANY reported LANTUS problem on Dec 11, 2006. Female patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: nasal cavity cancer. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5273829-8
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 12, 2007. Female patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: retinal haemorrhage. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5274157-7
Physician from UNITED STATES reported LANTUS problem on Mar 14, 2007. Female patient, weighting 170.0 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: balance disorder, blepharitis, blood glucose decreased, blood glucose increased, dry eye, eye infection, fatigue, gait disturbance, gastric disorder. LANTUS dosage: unknown. During the same period patient was treated with OPTICLIK, NOVOLOG, ACTOS, HYDROCODONE, LISINOPRIL, PREMARIN, AMITRIPTYLINE, GABAPENTIN. Patient recovered.

Lantus Side Effects Report #5274159-0
LANTUS problem was reported by a Physician from BRAZIL on Mar 16, 2007. Female patient, 28 years of age, weighting 110.2 lb, was diagnosed with depression and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: dyspnoea, headache, hyperglycaemia, hypoglycaemia, hypoglycaemic unconsciousness, kidney infection, nephrolithiasis, pyrexia, urinary incontinence. LANTUS dosage: unknown. During the same period patient was treated with PURAN T, HUMALOG, TRYPTANOL, PAMELOR, BUSCOPAN. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5274160-7
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Mar 08, 2007. Male patient, weighting 295.4 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: weight increased. LANTUS dosage: unknown. During the same period patient was treated with HUMALOG, PROPRANOLOL, ZETIA, ASPIRIN, LEVOCARNITINE, HYDROCHLORTHIAZID, NIACIN. Patient recovered.

Lantus Side Effects Report #5274161-9
LANTUS problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 14, 2007. Female patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, convulsion. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5275650-3
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Mar 16, 2007. Female patient, 53 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: accidental overdose, blood glucose decreased, hyperhidrosis, hypoglycaemic seizure, incoherent, tremor. LANTUS dosage: unknown. During the same period patient was treated with PANCREASE, ADVAIR DISKUS, AZMACORT, TOPAMAX, DEPAKOTE, AMITRIPTYLINE. Patient died on 11/20/2006.

Lantus Side Effects Report #5275652-7
LANTUS problem was reported by a Physician from UNITED KINGDOM on Mar 19, 2007. Male patient, 56 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: chest discomfort, lower respiratory tract infection. LANTUS dosage: unknown. During the same period patient was treated with NOVORAPID, METFORMIN, AMLODIPINE, LISINOPRIL, ASPIRIN, LANSOPRAZOLE, GAVISCON. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5275653-9
Physician from ITALY reported LANTUS problem on Mar 19, 2007. Male patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, ketosis. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5275654-0
LANTUS problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 20, 2007. Female patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood ketone body increased, dehydration, hyperglycaemia, influenza. LANTUS dosage: unknown. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5276932-1
Physician from GERMANY reported LANTUS problem on Mar 21, 2007. Female patient was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: colon cancer. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5279080-X
LANTUS problem was reported by a Consumer or non-health professional from SPAIN on Mar 22, 2007. Male patient, 69 years of age, weighting 168.7 lb, was diagnosed with diabetes mellitus non-insulin-dependent, hypertension and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: effusion, erythema, eye disorder, eye infection, eye inflammation, formication, hyperglycaemia, vascular rupture. LANTUS dosage: unknown. During the same period patient was treated with ARADOIS, AMARYL. Patient recovered.

Lantus Side Effects Report #5279081-1
Consumer or non-health professional from AUSTRALIA reported LANTUS problem on Mar 23, 2007. Male patient, 76 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: eye haemorrhage, ocular hyperaemia. LANTUS dosage: unknown. Patient recovered.

Lantus Side Effects Report #5280531-5
LANTUS problem was reported by a Physician from SWITZERLAND on Mar 27, 2007. Male patient, 76 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, hypoglycaemic seizure, myocardial infarction. LANTUS dosage: unknown. During the same period patient was treated with APIDRA. Patient was hospitalized. Patient recovered.

Lantus Side Effects Report #5283516-8
Consumer or non-health professional from UNITED STATES reported LANTUS problem on Mar 22, 2007. Female patient, 64 years of age, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, cerebrovascular accident, hemiplegia, visual disturbance. LANTUS dosage: unknown. During the same period patient was treated with GLUCOPHAGE. Patient recovered.

Lantus Side Effects Report #5283517-X
LANTUS problem was reported by a Consumer or non-health professional from RUSSIAN FEDERATION on Mar 29, 2007. Female patient, 70 years of age, was diagnosed with diabetes mellitus and was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: asthenia, chills, dizziness, loss of consciousness, nausea, vomiting. LANTUS dosage: unknown. Patient recovered.

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Drug Information: Insulin Glargine (rDNA origin) Injection

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a600027.html

(in' su lin glar' geen)

Why is this medication prescribed?

Insulin glargine is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). It is also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need long-acting insulin to control their diabetes. Insulin glargine is a long-acting, man-made version of human insulin. Insulin is a hormone made in the pancreas. Insulin helps move sugar from the blood into other body tissues where it is used for energy. It also helps the body break down carbohydrates, fats, and proteins from the diet. In a person with diabetes, the pancreas does not produce enough insulin for the body's needs, so additional insulin is required. People with diabetes may gradually develop serious nerve, blood vessel, kidney, and eye problems if the diabetes is not controlled properly.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Insulin glargine comes as an injection to inject subcutaneously (beneath the skin, not into a vein). It is injected once a day at bedtime. The medication comes in vials (bottles) and also prefilled containers called cartridges. The amount of insulin glargine you need depends on diet, other diseases, exercise, and other drugs you are taking and may change with time. Your doctor will tell you how much you should take. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take insulin glargine exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Insulin glargine controls diabetes but does not cure it. It must be taken regularly. Continue to take insulin glargine even if you feel well. Do not stop taking insulin glargine without talking to your doctor.

You do not have to shake the vial or cartridge of insulin glargine before use. Do not dilute or mix insulin glargine with any other insulin or solution. The syringe must not have any other medicine or residue in it.

If your insulin glargine comes in cartridges, the medication will already be inside. You must only use the OptiPen One Insulin Delivery Device with the cartridges. Before you use the device for the first time, read the written directions that come with it. Ask your doctor, pharmacist, or nurse to show you the right way to use this device. Practice while your health care provider watches.

If your insulin glargine comes in vials, you will have to withdraw (draw up) the medication into a syringe. Before you do this for the first time, read the written directions that come with it. Ask your doctor or pharmacist to show you the right way to withdraw the insulin glargine and to inject the medication subcutaneously. Practice while your health care provider watches.

If your insulin glargine comes in vials you will need to use syringes. Always use a syringe that is marked for U-100 insulin products. If you use the wrong syringe, you may get the wrong dose, and your blood glucose level may end up being too low or too high.

Plastic syringes are disposable; use a new one for each injection. Used needles will hurt more and may cause an infection. Never share needles and syringes. To withdraw insulin glargine into the syringe, follow these steps:

  • Wash your hands.
  • Hold the vial in your hands to warm the medicine. Look at the medicine in the vial. Make sure it is clear and colorless. If it is cloudy or has particles (specks) in it, throw the vial away and get a new one.
  • If you are using a new vial, remove the protective cap. Do not remove the stopper (the rubber inside the cap).
  • Wipe the top of the vial with an alcohol swab or cotton dipped in rubbing alcohol.
  • It is easier to withdraw insulin glargine if you first inject air into the vial. To do this, pull the plunger (the cylinder inside the syringe) back to the number of insulin glargine units you will have to take. Now your syringe is filled with the right amount of air. Insert the needle through the rubber cap and push on the plunger to inject the air into the vial.
  • Keep the syringe in the vial and turn both upside down. Hold the syringe and vial firmly with one hand.
  • Make sure the tip of the needle is in the insulin. With your free hand, pull back on the plunger to withdraw insulin glargine into the syringe, and measure the correct number of units of insulin glargine.
  • Before you take the needle out of the vial, be sure that there are no bubbles in the syringe. If there are bubbles in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin glargine back in until you have the correct dose.
  • Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.
  • If you have trouble seeing the small markings on the syringe, have someone help you. Also, let your doctor and pharmacist know about this problem. They can provide syringes that are easier to read, special tools to help you fill the syringe, or prefilled syringes.

To inject your insulin glargine dose, follow these steps:

  • Decide on an injection area—either your abdomen, buttocks, thighs, or arms.
  • Clean the skin at the injection site with an alcohol pad or cotton dipped in rubbing alcohol.
  • Pinch a fold of skin with your fingers at least 3 inches apart and insert the needle at a 45- to 90-degree angle.
  • Then slowly push the plunger of the syringe all the way, making sure you have injected all the insulin glargine. Leave the needle in the skin for several seconds.
  • Pull the needle straight out and press lightly on the spot where you injected yourself for several seconds. Do not rub the area.
  • Follow the directions given to you for throwing away the needle and syringe.

Use a different site for each injection, about 1 inch away from the previous injection but in the same general area (for example, the thigh). Use all available sites in the same general area before switching to a different area (for example, the upper arm). Do not use the same injection site more often than once every month.

What special precautions should I follow?

Before taking insulin glargine,

  • tell your doctor and pharmacist if you are allergic to insulin or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetazolamide (Diamox); AIDS antiviral medications; albuterol (Proventil, Ventolin); allergy or cold medications; angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril (Capoten), enalapril (Vasotec), or lisinopril (Prinivil, Zestril); antibiotics; antipsychotics such as fluphenazine (Prolixin), mesoridazine (Serentil), or thioridazine (Mellaril); beta-blockers such as propranolol (Inderal); calcitonin (Calcimar); chloroquine (Aralen); chlorpromazine (Thorazine); clofibrate (Atromid-S); clonidine (Catapres); corticosteroids such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone); danazol (Danocrine); disopyramide (Norpace); diuretics ('water pills'); epinephrine; estrogens; fenofibrate (TriCor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); guanethidine (Ismelin); isoniazid (INH); lithium (Eskalith, Lithobid); mebendazole (Vermox); medications that contain alcohol or sugar; morphine (MS Contin, others); niacin; nicotine; octreotide (Sandostatin); oral contraceptives (birth control pills); oral medications for diabetes; pentamidine (Pentam); phenelzine (Nardil); phenytoin (Dilantin); prochlorperazine (Compazine); promethazine (Phenergan); propoxyphene (Darvon); reserpine (Serpalan, others); salicylates such as aspirin, diflunisal (Dolobid), or salsalate (Disalcid); somatropin (human growth hormone); sulfa drugs; sulfinpyrazone (Anturane); terbutaline (Brethine, Bricanyl); thyroid medications; tranylcypromine (Parnate); trimeprazine (Temaril); and vitamins or herbal products.
  • tell your doctor if you have or have ever had thyroid, liver, or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking insulin glargine, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking insulin glargine.
  • tell your doctor if you have fever, infection, injury, or illness with vomiting or diarrhea. These may affect your blood sugar level.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet. Do not start a diet or an exercise program without talking to your doctor. Your insulin dose may need to be changed.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin glargine.

What should I do if I forget a dose?

Before you start taking insulin glargine, ask your doctor what to do if you forget to take a dose or if you accidentally take an extra dose. Write these directions down so you can refer to them later.

What side effects can this medication cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:

  • shakiness
  • dizziness or lightheadedness
  • sweating
  • nervousness or irritability
  • sudden changes in behavior or mood
  • headache
  • numbness or tingling around the mouth
  • weakness
  • pale skin
  • hunger
  • clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

  • confusion
  • seizures
  • loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

  • extreme thirst
  • frequent urination
  • extreme hunger
  • weakness
  • blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

  • dry mouth
  • upset stomach and vomiting
  • shortness of breath
  • breath that smells fruity
  • decreased consciousness

Insulin glargine can cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • redness, swelling, pain, and itching at the injection site
  • changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)

If you experience any of the following symptoms, call your doctor immediately:

  • exaggerated sunburn
  • difficulty speaking or moving
  • skin rash or hives all over the body
  • itching or redness
  • swelling of hands or feet
  • difficulty swallowing
  • wheezing (trouble breathing)
  • fast pulse
  • low blood pressure

What storage conditions are needed for this medicine?

Store unopened insulin glargine vials and cartridges in the refrigerator. Never allow insulin glargine to freeze; do not use insulin glargine that has been frozen and thawed. Never heat insulin glargine to warm it. Unopened refrigerated insulin glargine can be stored until the date shown on the company's label.

If no refrigerator is available (for example, when on vacation), store the vials or cartridges at room temperature and away from direct sunlight and extreme heat. Unrefrigerated 10-mL vials or cartridges can be used within 28 days or they must be thrown away. Unrefrigerated 5-mL vials can be used for 14 days or they must be thrown away. Refrigerated 5-mL vials can be used for up to 28 days. Once the cartridge is placed in the OptiPen One Insulin Delivery Device, do not refrigerate. Throw away any insulin that has been exposed to extreme heat or cold.

Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to insulin glargine. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

Your dose of insulin glargine may need to be changed when you are ill (especially with fever, vomiting, or diarrhea), have emotional changes or stress, gain or lose weight, or change the amount of food you eat or amount of exercise you do. If any of these things happen, call your doctor.

See your dentist twice yearly; see your eye doctor regularly; get your blood pressure checked regularly.

If you travel across time zones, ask your doctor how to time your injections. When you travel, take extra insulin and supplies with you.

Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected. Wear medical alert identification (a bracelet or tag) that says you have diabetes.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Lantus®

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